CLO-SURPLUS P.A.D.
FDA 510(k) clearance K112961 · decided 2011-10-31
Clearance details
- K-number
- K112961
- Device name
- CLO-SURPLUS P.A.D.
- Applicant
- Scion Cardio-Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-04
- Decision date
- 2011-10-31
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Melbourne, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.